While most herbal suppliers recognise the merits of the law in
the long-term, many are worried about the high costs of complying
with all elements of the new law.

"The overriding concern about this directive is the
cost,"​ confirms Penny Viner, chairwoman of the Herbal Forum, a
group of industry and practitioner associations.

"A lot of companies in the herbal industry are SMEs,"​ she
added.

To register a product as a traditional medicinal herbal,
allowing the company to make a low-level claim on it across all
member state markets, involves compiling data to prove a plant's
traditional use as a medicine for at least 15 years in the European
Union.

Manufacturers must then meet ongoing quality standards and have
data on the safety of the production process, a level similar to
that required by medicines manufacturers.

They must also issue consumer information on the product and
directions for its safe use, in braille as well as standard print,
adding to initial costs.

"If a firm does not already have a medicines manufacturing
licence they are required to invest significantly in quality
control,"​ noted Viner.

She added that the UK market is likely to see higher costs than
others because of the great number of combination products on
offer.

"Doing traceability on herbs back to the field, for the
number of different raw materials in some traditional herbal
products will be nigh on impossible,"​ she said.

Raw material suppliers will be impacted too as the more evidence
they can provide of good agricultural practice, the better equipped
their customers will be for registration of their products.

"Because of the costs, there will be some product
losses,"​ said Viner. "And I think it is probable that there
will be price rises."

"But to a degree, some of the increased costs are inescapable
and it really is about planning ahead," she concluded.

The new directive must be written into the national laws of all
member states by 30 October, however most states will permit a
transitional phase, giving companies until April 2011 to adapt to
new arrangements.

Companies serious about gaining a THMPD registration are already
holding meetings with their national medicines authorities, says
Viner. Others should be looking at the alternative options under
food law.

With the planned introduction of health claims on foods, this
option could allow some herbal product makers to make claims even
though they are not registered as traditional medicines.

"Of course the industry is concerned that there will still be
a large market that goes underground or sells over the
Internet,"​ Viner noted.